手术是局部晚期分化型甲状腺癌（DTC）的主要治疗方法。然而，一些局部晚期患者不适合行R0/1切除术。目前关于局部晚期DTC新辅助治疗的证据有限。舒尼替尼靶向多个激酶，在无放射碘耐药的DTC患者中具有高效、可耐受和安全的特点。此外，舒尼替尼联合托瑞帕利单抗（一种抗PD-1抗体）在晚期实体瘤中显示了令人鼓舞的抗肿瘤活性。本研究旨在评估舒尼替尼联合托瑞帕利单抗在局部晚期DTC新辅助治疗中的疗效和安全性。在这项单臂、Ⅱ期研究中，符合病理学确认的不能手术切除或边缘可手术切除的DTC患者符合入选条件，并接受每天口服250毫克舒尼替尼和每3周静脉注射240毫克托瑞帕利单抗的联合治疗。治疗持续至满意的根治性手术、疾病进展、患者撤回同意、无法接受的毒性反应或研究者判断为止。主要终点是客观缓解率（ORR）。次要终点包括R0/1切除率、不良事件（AEs）等。结果：共有10名患者入组并接受至少4个周期的治疗。ORR为60%。9名患者在新辅助治疗后接受了R0/1切除。目标病变直径总和最佳百分比变化的中位数为32%。大多数不良事件（AEs）为1级或2级。舒尼替尼联合托瑞帕利单抗作为局部晚期DTC的新辅助治疗是可行的，并且大部分患者实现了R0/1切除。它为局部晚期DTC提供了新的选择，并需要进一步研究。©2023.外科肿瘤学会。

Surgery is the primary treatment for locally advanced differentiated thyroid cancer (DTC). However, some locally advanced patients are not candidates for R0/1 resection. There is limited evidence of neoadjuvant treatment in locally advanced DTC. Surufatinib targets multiple kinases, which is efficient, tolerable, and safe in patients with radioiodine-refractory DTC. In addition, surufatinib plus toripalimab (an anti-PD-1 antibody) showed encouraging antitumor activity in advanced solid tumors. This study was designed to evaluate the efficacy and safety of surufatinib plus toripalimab in locally advanced DTC in the neoadjuvant setting.In this single-arm, phase II study, patients with pathologically confirmed unresectable or borderline resectable DTC were eligible and received a combination of 250 mg of surufatinib (orally daily) with 240 mg of toripalimab (intravenous, every 3 weeks). Treatment continued until satisfied for curative surgery, disease progression, withdrawal of consent, unacceptable toxicity, or investigator decision. Primary endpoint was objective response rate (ORR). Secondary endpoints included R0/1 resection rate, adverse events (AEs), etc. RESULTS: Ten patients were enrolled and received at least 4 cycles of treatment. The ORR was 60%. Nine patients received R0/1 resections after neoadjuvant treatment. The median best percentage change in the sum of the target lesion diameter was 32%. Most adverse events (AEs) were grade 1 or 2.Surufatinib in combination with toripalimab as neoadjuvant therapy for locally advanced DTC was feasible, and the majority of patients achieved R0/1 resection. It represents a new option for locally advanced DTC and needs further investigation.© 2023. Society of Surgical Oncology.